Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial)

NCT ID: NCT06974344

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2030-09-01

Brief Summary

The goal of this clinical trial is to compare two treatments for regulating blood flow in small liver grafts during living donor liver transplantation (LDLT). The main questions it aims to answer are:

• Is octreotide (a medication) as effective or better than splenic artery ligation (surgery) in reducing complications after transplantation?
• Which treatment better controls blood flow while causing fewer side effects?

Researchers will compare octreotide (given through an IV) to splenic artery ligation (performed during surgery) to see which approach works best for patients receiving small liver grafts.

Participants will:

• Be randomly assigned to receive either octreotide or splenic artery ligation during their transplant surgery
• Have their liver blood flow monitored closely during and after surgery

Be followed for 90 days and 1 year to track complications, hospital stay, recovery, and survival.

This study may help doctors choose safer, more effective treatments for patients needing small liver grafts.

Detailed Description

This randomized controlled trial (SCALOP-RCT) investigates two strategies for managing portal hyperperfusion in adults receiving small living donor liver transplants (graft-to-recipient weight ratio <0.80%). Small grafts are prone to injury from high venous portal and low hepatic artery flow, leading to small-for-size syndrome (SFSS), a major cause of transplant failure.

Interventions Compared

• Octreotide: A somatostatic analogue that reduces portal venous flow and increased hepatic artery flow to the liver by constricting blood vessels, given continuously through an IV during and after surgery.
• Splenic Artery Ligation (SAL): A surgical procedure that ties off the artery supplying the spleen, indirectly lowering portal venous flow.

Study Design

• Randomization: Participants are assigned 1:1 to octreotide or SAL during transplant surgery.
• Rescue Protocol: If portal venous flow remains too high after the initial treatment, patients may switch to the alternative therapy (crossover).
• Blinding: Surgeons know the treatment, but outcome assessors and data analysts do not.

Key Assessments

• Primary: Total complication burden at 90 days (Comprehensive Complication Index(R) (CCI(R)).
• Secondary: Blood flow measurements, early liver function, hospital stay, survival, and quality of life.
• Rationale: Current approaches vary widely, with no consensus on whether medications or surgery work better. This trial will provide evidence to standardize care, potentially improving graft survival and expanding donor options.
• Population: 80 adults (18-70 years) undergoing LDLT at a single tertiary center.
• Innovation: First head-to-head comparison of these strategies with rigorous hemodynamic monitoring and crossover rescue design.

Conditions

Small-for-Size Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Octreotide Infusion Arm

Continuous intravenous octreotide (1 mcg/kg/hr) initiated at liver graft reperfusion and continued postoperatively until hemodynamic stability is achieved.

Group Type: ACTIVE_COMPARATOR

Octreotide (drug)

Intervention Type: DRUG

Continuous intravenous octreotide acetate infusion initiated at hepatic reperfusion during living donor liver transplantation (LDLT). The initial dose is 1 mcg/kg/hr, titrated intraoperatively based on portal venous flow (PVF) and hepatic artery flow / resistive index (RI) measurements. The infusion continues postoperatively in the ICU until stable graft hemodynamics are achieved (target PVF \<5 mL/min/g and presence of diastolic hepatic arterial flow). Dose adjustments are permitted for efficacy or safety concerns, with all modifications documented. The intervention is administered via central venous access using standard infusion protocols

Splenic Artery Ligation (SAL) Arm

Intraoperative ligation of the splenic artery using non-absorbable suture near its origin.

Group Type: ACTIVE_COMPARATOR

Splenic Artery Ligation (SAL)

Intervention Type: PROCEDURE

Intraoperative ligation of the splenic artery performed during living donor liver transplantation (LDLT) using non-absorbable suture material (e.g., polypropylene). The ligation is typically placed near the splenic artery origin for maximal portal flow modulation, with exact positioning determined by surgeon assessment of vascular anatomy and intraoperative hemodynamics (targeting portal venous flow \<5 mL/min/g). The procedure is performed under direct visualization during the transplant operation, with post-ligation Doppler ultrasound confirmation of hemodynamic response within 60 minutes of biliary anastomosis.

Interventions

Octreotide (drug)

Continuous intravenous octreotide acetate infusion initiated at hepatic reperfusion during living donor liver transplantation (LDLT). The initial dose is 1 mcg/kg/hr, titrated intraoperatively based on portal venous flow (PVF) and hepatic artery flow / resistive index (RI) measurements. The infusion continues postoperatively in the ICU until stable graft hemodynamics are achieved (target PVF \<5 mL/min/g and presence of diastolic hepatic arterial flow). Dose adjustments are permitted for efficacy or safety concerns, with all modifications documented. The intervention is administered via central venous access using standard infusion protocols

Intervention Type: DRUG

Splenic Artery Ligation (SAL)

Intraoperative ligation of the splenic artery performed during living donor liver transplantation (LDLT) using non-absorbable suture material (e.g., polypropylene). The ligation is typically placed near the splenic artery origin for maximal portal flow modulation, with exact positioning determined by surgeon assessment of vascular anatomy and intraoperative hemodynamics (targeting portal venous flow \<5 mL/min/g). The procedure is performed under direct visualization during the transplant operation, with post-ligation Doppler ultrasound confirmation of hemodynamic response within 60 minutes of biliary anastomosis.

Intervention Type: PROCEDURE

Other Intervention Names

Octreotide acetate; Sandostatin®; Somatostatin analogue

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and <70 years

2. Male and female genders

3. Undergoing Living Donor Liver Transplant (LDLT)

4. All indications

5. Receiving a small-for-size graft requiring portal flow modulation

6. Informed consent provided.

Exclusion Criteria

1. Deceased Donor Liver Transplantation (DDLT)

2. Dual LDLT or dual LDLT/DDLT

3. Pregnancy

4. Known allergy to Octreotide / Somatostatin analogue

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dieter C. Broering, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Dimitri A. Raptis, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Massimo Malago, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Locations

Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Central Contacts

Dieter C. Broering, MD, PhD

Role: CONTACT

dbroering@kfshrc.edu.sa

+966 11 464 7272

Dimitri A. Raptis, MD, MSc, PhD

Role: CONTACT

draptis@kfshrc.edu.sa

+966530330809

Facility Contacts

Dieter C. Broering, MD, PhD

Role: primary

dbroering@kfshrc.edu.sa

+966 11 464 7272

Dimitri A. Raptis, MD, MSc, PhD

Role: backup

draptis@kfshrc.edu.sa

+966530330809

Other Identifiers

RAC2241241

Identifier Type: -

Identifier Source: org_study_id